Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity
NCT ID: NCT02945410
Last Updated: 2019-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2016-09-30
2019-02-28
Brief Summary
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Detailed Description
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Prior to the study start, participants will be weighed and body composition will be determined using calipermetry (7 sites) and bioelectrical impedance. Peak oxygen uptake (VO2peak) will be assessed using an incremental exercise test on a bicycle ergometer.
2. Randomization
Participants will proceed through each of the following conditions lasting 5 days:
CR-LP: Participants will be restricted to 30 kcal/kg FFM/day and protein intake will be low (0.8 g/kg BW/day).
CR-HP: Participants will be restricted to 30 kcal/kg FFM/day and protein intake will be high (1.7 g/kg BW/day).
CON: Participants will be in energy balance and consume 1.7 g protein/kg BW/day.
3. Diet Prescription
Dietary energy intake will be controlled using clinical products and maltodextrin to meet target energy intakes. Participants will received calcium and Vitamin D supplementation throughout the study.
4. Exercise Prescription
During all conditions, participants will conduct daily supervised exercise on a bicycle ergometer at an exercise intensity of 60% VO2peak. Exercise duration will be adjusted individually such that exercise energy expenditure will amount to 15 kcal/kg FFM/day. Additional exercise and intense physical activity will be prohibited.
5. Assessments
The following assessments will be conducted prior to the start of each condition as well as upon completion of each condition: body weight and composition (impedance), fasting blood draw for assessment of metabolic and anabolic hormones, resting metabolic rate, aerobic fitness (VO2peak), and questionnaires.
6. Washout
Once a participant has completed a study condition, participant will be allowed a washout of at least 14 days to allow protein balance to return to baseline (Hoffer \& Forse, 1990). During this time, participants will resume their regular diet and physical activity.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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Caloric Restriction and High Protein
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
Caloric Restriction
Participants will consume 30 kcal/kg FFM/day.
Protein
Participants will consume 1.7 g protein/kg BW/day.
Exercise
Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D
Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin
Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
Caloric Restriction and Normal Protein
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
Caloric Restriction
Participants will consume 30 kcal/kg FFM/day.
Exercise
Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D
Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin
Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
Energy Balance
Participants will be in energy balance and consume 1.7 g protein/kg BW/day.
Protein
Participants will consume 1.7 g protein/kg BW/day.
Exercise
Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D
Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin
Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
Interventions
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Caloric Restriction
Participants will consume 30 kcal/kg FFM/day.
Protein
Participants will consume 1.7 g protein/kg BW/day.
Exercise
Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D
Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin
Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
Eligibility Criteria
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Inclusion Criteria
* Body mass index: 19-25 kg/m2
* \< 15% body fat
Exclusion Criteria
* Smoking
* Type I, type II diabetes, or history of high fasting glucose;
* History of high blood pressure and/or use of medication for hypertension;
* History of Dyslipidemia, or on lipid-lowering medication;
* Underlying health condition and/or use of medication that could interfere with any of our study outcomes.
* History or current diagnosis of a clinical eating disorder
* Failure to adhere to study protocol
19 Years
30 Years
MALE
Yes
Sponsors
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University of Nebraska Lincoln
OTHER
Responsible Party
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Principal Investigators
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Karsten Koehler, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska Lincoln
Locations
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Sports and Exercise Nutrition Laboratory, Department of Nutrition and Health Sciences, Ruth Leverton Hall
Lincoln, Nebraska, United States
Countries
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References
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Weinheimer EM, Sands LP, Campbell WW. A systematic review of the separate and combined effects of energy restriction and exercise on fat-free mass in middle-aged and older adults: implications for sarcopenic obesity. Nutr Rev. 2010 Jul;68(7):375-88. doi: 10.1111/j.1753-4887.2010.00298.x.
Forbes GB. Body fat content influences the body composition response to nutrition and exercise. Ann N Y Acad Sci. 2000 May;904:359-65. doi: 10.1111/j.1749-6632.2000.tb06482.x.
Areta JL, Burke LM, Camera DM, West DW, Crawshay S, Moore DR, Stellingwerff T, Phillips SM, Hawley JA, Coffey VG. Reduced resting skeletal muscle protein synthesis is rescued by resistance exercise and protein ingestion following short-term energy deficit. Am J Physiol Endocrinol Metab. 2014 Apr 15;306(8):E989-97. doi: 10.1152/ajpendo.00590.2013. Epub 2014 Mar 4.
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Wasserman DH, Kang L, Ayala JE, Fueger PT, Lee-Young RS. The physiological regulation of glucose flux into muscle in vivo. J Exp Biol. 2011 Jan 15;214(Pt 2):254-62. doi: 10.1242/jeb.048041.
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Dulloo AG, Jacquet J, Montani JP, Schutz Y. How dieting makes the lean fatter: from a perspective of body composition autoregulation through adipostats and proteinstats awaiting discovery. Obes Rev. 2015 Feb;16 Suppl 1:25-35. doi: 10.1111/obr.12253.
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Ihle R, Loucks AB. Dose-response relationships between energy availability and bone turnover in young exercising women. J Bone Miner Res. 2004 Aug;19(8):1231-40. doi: 10.1359/JBMR.040410. Epub 2004 Apr 19.
De Souza MJ, Williams NI. Beyond hypoestrogenism in amenorrheic athletes: energy deficiency as a contributing factor for bone loss. Curr Sports Med Rep. 2005 Feb;4(1):38-44. doi: 10.1007/s11932-005-0029-1.
Rizzoli R, Bianchi ML, Garabedian M, McKay HA, Moreno LA. Maximizing bone mineral mass gain during growth for the prevention of fractures in the adolescents and the elderly. Bone. 2010 Feb;46(2):294-305. doi: 10.1016/j.bone.2009.10.005. Epub 2009 Oct 17.
Pikosky MA, Smith TJ, Grediagin A, Castaneda-Sceppa C, Byerley L, Glickman EL, Young AJ. Increased protein maintains nitrogen balance during exercise-induced energy deficit. Med Sci Sports Exerc. 2008 Mar;40(3):505-12. doi: 10.1249/MSS.0b013e31815f6643.
Pasiakos SM, Margolis LM, McClung JP, Cao JJ, Whigham LD, Combs GF, Young AJ. Whole-body protein turnover response to short-term high-protein diets during weight loss: a randomized controlled trial. Int J Obes (Lond). 2014 Jul;38(7):1015-8. doi: 10.1038/ijo.2013.197. Epub 2013 Oct 29.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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15895
Identifier Type: -
Identifier Source: org_study_id